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job_organization_name

field_job_occupational_field_parents_all

city

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<h3>Job Description</h3>
Job Description
CFD Research is seeking a mid-level research engineer to support the research and development of multiple simulation codes with a primary focus on supporting the CFD Research HEAT software package. The candidate will be part of a team focused on developing tools in support of hypersonic vehicle modeling including: TPS aerothermal response, boundary layer modeling, material ablation and decomposition, hypersonic external flow, Lagrangian particle tracking, mesh shape change and grid adaptation, and more. The candidate should have experience deriving and implementing numerical solvers for physics-based equations as well as code development experience in Fortran, C/C++, and Python.
Basic Qualifications:
<ul>
<li>
Candidate must be a US Citizen and meet eligibility to obtain (and maintain) a Secret Clearance
</li>
<li>
MS in Aerospace or Mechanical Engineering (or related STEM discipline) + at least two years relevant experience
</li>
<li>
Candidate must have experience in compiled languages such as Fortran and/or C/C++ and knowledge of code compilation and development on Linux.
</li>
<li>
Experience with Python programming
</li>
<li>
Additional technical skills as follows: Gitlab, CMake, OOP, Bash/Power Shell, compressible flows, numerical methods, linear algebra, hypersonics coursework
</li>
</ul>
Preferred Qualifications:
<ul>
<li>
Active secret level clearance
</li>
<li>
PhD preferred
</li>
<li>
Experience developing CFD codes, linear solvers, or algorithms of similar complexity
</li>
<li>
Additional preferred skills/experience: Fortran 2008+, Git, Docker, Valgrind, gprof (or Intel equivalents), and parallel computing / multi-threading.
</li>
</ul>
Location: This role is based in the Huntsville, AL area, and is 100% onsite.
About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace &amp; Defense, Biomedical &amp; Life Sciences, Intelligence &amp; Sensing, and Energy &amp; Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for four of the last five years. Learn more at <a href="http://www.cfd-research.com" target="_blank">www.cfd-research.com</a>
 
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers a highly competitive insurance package, including medical, vision, and dental insurance. We offer company paid leave, compensation time, parental leave, long-term and short-term disability, accidental death and dismemberment, and life insurance. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.
CFD Research is an EO employer - Veterans/Disabled and other protected categories
 Job Posted by ApplicantPro

Senior Research Engineer (Computational Engineering / Development)

<h3>Job Description</h3>
Job Description Company Description:&nbsp; SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and sell the world's first and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart as bridge to transplant for patients suffering from biventricular heart failure The SynCardia Total Artificial Heart™ is available in two sizes to accommodate patients’ diverse physiologies. The Freedom Portable Driver™ allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant. The SynCardia Total Artificial Heart™ has been successfully used in over 2,000 patients and is the most widely used and extensively studied total artificial heart in the world. For additional information and label information, visit us at <a href="http://www.syncardia.com" target="_blank">www.syncardia.com</a>. Position Description:&nbsp; SynCardia Systems, LLC is seeking a Mechanical Engineer to support the production and manufacturing of our Total Artificial Heart System. This role focuses on sustaining engineering efforts, ensuring compliance with regulatory standards, and driving continuous process improvements. Responsibilities:&nbsp;
<ul>
<li>Provide mechanical engineering and project leadership to support existing Total Artificial Heart System productions in Sustaining Engineering and manufacturing as required by business needs.</li>
<li>Provide engineering information by answering questions and requests.</li>
<li>Maintain product and company reputation by complying with government regulations.</li>
<li>Maintain good documentation practices for all aspects of work.</li>
<li>Participate in related company projects to gain a solid working understanding of SynCardia business and quality systems.&nbsp;</li>
<li>Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.</li>
<li>Develop and manage budgets, timelines, and resources for manufacturing projects.</li>
<li>Train and mentor team members to promote professional growth and development.</li>
<li>Develop and execute plans to ramp up production capacity in response to increased demand or new product introductions</li>
<li>Manage the transfer of production processes and equipment from development to manufacturing, ensuring all requirements are met and risks are mitigated.</li>
<li>Develop and validate tooling designs which meet the requirements of the manufacturing process, including precision, repeatability, and ease of use.</li>
<li>Use value stream mapping to visualize and analyze the flow of materials and information through the production system, and identify opportunities for improvement.</li>
<li>Identify and eliminate waste in the manufacturing process, including defects, overproduction, waiting time, excess inventory, unnecessary motion, and unused talent.</li>
<li>Confirm system and product capabilities by designing feasibility and testing methods.</li>
<li>Assist to create and revise product requirement specifications.</li>
<li>Prepare product test and investigation reports by collecting, analyzing, and summarizing information.</li>
<li>Research and champion an understanding of regulatory requirements as related to mechanical engineering for SynCardia products.</li>
</ul>
Responsibility &amp; Authority Affecting Quality
<ul>
<li>Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.</li>
<li>Identify and record potential problems relating to the product, process and Quality System.</li>
<li>Initiate, recommend or provide solutions through designated channels.</li>
<li>Record and/or report all instances of customer feedback on product.</li>
</ul>
Requirements &amp; Education:
<ul>
<li>SolidWorks CAD software or equivalent 3D modeling software and tool design</li>
<li>Demonstrated experience in applying Lean Six Sigma methodologies to improve manufacturing processes and drive continuous improvement initiatives.</li>
<li>Experience leading manufacturing projects</li>
<li>Detailed dimensioned drawings, for components &amp; assemblies</li>
<li>Knowledge of pneumatic systems</li>
<li>Basic knowledge of mechanical measurements tools and techniques</li>
<li>Experience with geometric dimensioning and tolerancing per ASME Y14.5M</li>
<li>Excellent communication skills</li>
<li>Excellent technical writing skills</li>
<li>Strong organizational skills</li>
<li>Detail oriented</li>
<li>Ability to handle multiple tasks simultaneously</li>
<li>A team player / collaborative </li>
<li>Ability to react and learn quickly in a dynamic environment</li>
<li>Bachelor's Degree or Master's Degree, or 5 years of relevant experience in Mechanical Engineering or Biomedical Engineering</li>
<li>General understanding of mechanical design philosophies, process, tools and standards</li>
<li>Regulated device experience&nbsp;</li>
</ul>
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hQraLEfn1d

Senior Manufacturing Engineer - SynCardia Systems, LLC

<h3>Job Description</h3>
Job Description
Our client, a leader in the manufacturing of devices and components for major medical device companies, is looking for a Principal Application Engineer to join their organization. 
They offer competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. They maintain a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous improvement. The company is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485. 
SUMMARY OF POSITION:
Reporting to the Sr. Engineering Manager, this position will have direct responsibility for key production-related deliverables including, but not limited to Manufacturing plan; Capacity planning; COGS estimation; Process validations; Capital equipment specifications and procurement; Production line set-up, as well as coordinate the launch of new products into production. The company manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. 
ESSENTIAL FUNCTIONS:
<ul>
<li>This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure). </li>
</ul>
<ul>
<li>Develop and perform installation, operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements. </li>
</ul>
<ul>
<li>Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments. </li>
</ul>
<ul>
<li>Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities. </li>
</ul>
<ul>
<li>Actively participate in process development projects and DFM with internal and external teams </li>
</ul>
<ul>
<li>Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates </li>
</ul>
<ul>
<li>Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements. </li>
</ul>
<ul>
<li>Create 1st pcs and in-process inspection plans. </li>
</ul>
<ul>
<li>Design fixtures for post processing operations. </li>
</ul>
<ul>
<li>Adapts machine or equipment design to facility and production conditions. </li>
</ul>
<ul>
<li>May incorporate inspection and test requirements into the production plan. </li>
</ul>
<ul>
<li>Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. </li>
</ul>
<ul>
<li>Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. </li>
</ul>
<ul>
<li>Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. </li>
</ul>
<ul>
<li>Identify and support business growth opportunities and present recommendations to management. </li>
</ul>
<ul>
<li>May be required to act as lead technical problem solver within area of specialization. </li>
</ul>
<ul>
<li>Develop and deliver presentations to communicate status, problem resolution or promote related business products. </li>
</ul>
QUALIFICATIONS:
<ul>
<li>Bachelor's degree (mechanical engineering, biomedical engineering, or related) required, with a related advanced degree preferred. </li>
</ul>
<ul>
<li>Minimum of 7 years' experience within a regulated industry (preferably in a Medical Device or Aerospace Manufacturer). </li>
</ul>
<ul>
<li>Project management experience - plan, development and execution. </li>
</ul>
<ul>
<li>Ability to read drawings and specifications containing GD&amp;T. </li>
</ul>
<ul>
<li>Familiarity with technologies and methods used to define how products are to be manufactured, how to conduct analysis, and meeting quality and compliance standards. </li>
</ul>
<ul>
<li>Extensive experience with transferring multi-disciplinary products from development to production. </li>
</ul>
<ul>
<li>Possess a high attention to detail. </li>
</ul>
<ul>
<li>Proficiency in SolidWorks </li>
</ul>
<ul>
<li>Proficient in the use of Microsoft Office, and Adobe products. </li>
</ul>
<ul>
<li>Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles. </li>
</ul>

Principal Application Engineer/CNC Programmer

<h3>Job Description</h3>
Job Description
Laser Engineer
Are you an innovative Field Service Engineer with a passion for cutting-edge technology? Join Sightpath Medical, the premier provider of mobile cataract and LASIK services in the U.S. You’ll have the unique opportunity to work with advanced ophthalmic equipment while supporting top surgeons in a fast-paced and rewarding environment. Whether you’re an entry-level candidate or bring years of experience, we offer knowledge, collaboration, and a shared commitment to excellence.

Why Sightpath Medical?
<ul>
<li>Comprehensive Training: Gain hands-on experience with the latest in ophthalmic laser technology. We provide all the training you need to excel in the field.</li>
<li>Independent Work Environment: You’ll have the autonomy to manage your work effectively while being part of an expert team.</li>
<li>Travel: You will have ownership of an assigned territory you will manage with a company provided vehicle and equipment. Every day is different. You will move from facility to facility providing expert service to our customers.</li>
<li>Work-life balance: With 8-10 case days per month, enjoy flexibility on non-case days when working from home or while traveling.</li>
<li>Medical benefits including health, dental, vision, short/long-term disability, and health savings account.</li>
<li>401(k) plan with employer contribution.</li>
<li>Health and Wellness Program to support your well-being.</li>
</ul>

What You’ll Do:
<ul>
<li>Technical Expertise: Install, de-install, calibrate, and operate transportable lasers and related equipment at customer sites.</li>
<li>Surgical Support: Ensure all equipment is programmed and calibrated to surgeon specifications prior to surgeries. You will also support the Surgeons during surgery to ensure customer satisfaction.</li>
<li>Preventative Maintenance: Perform routine maintenance and repairs to maximize equipment performance and minimize downtime.</li>
<li>Troubleshooting: Diagnose and resolve equipment issues efficiently, ensuring seamless surgical procedures.</li>
<li>Sterile Technique and Clinical: Adhere to sterile techniques during surgeries to ensure patient safety. Comprehensive training will be provided for all clinical aspects and requirements.</li>
<li>Manual Labor: Willing and able to assist with equipment setup and transport.</li>
<li>Other Duties: Flexibility to take on additional responsibilities as required.</li>
</ul>

Who We’re Looking For:
<ul>
<li>Technical Degree: Degree in Laser Electro-optics, Biomedical Equipment Technology, Electronics, or a similar field; military training in related fields is also acceptable.</li>
<li>Hands-On Experience: Proficiency with basic electronics and test equipment. Experience with laser systems is a plus.</li>
<li>Adaptable and Travel-Ready: Comfortable with driving to various locations in assigned territory and staying overnight when needed. All travel expenses are covered (hotel stays, gas for company vehicle, and meal allowances while traveling).</li>
<li>Driving Record: Able to produce a valid driver's license and pass a Motor Vehicle Report (MVR)/ driving record.</li>
<li>Excellent Communicator: Able to build strong relationships quickly with surgeons and their teams.</li>
<li>Self-assured: Able to thrive in high-pressure environments with confidence and professionalism.</li>
<li>Organized and Detail-Oriented: Skilled at managing equipment and completing administrative tasks required to support assigned territory.</li>
</ul>
<ul>
<li>Physical Demands: Ability to lift up to 100 lbs. and stand for extended periods.</li>
</ul>
SIGHTPATH is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age (40 and over), national origin or ancestry, physical or mental disability, genetic information or any other consideration protected by federal, state or local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including supervisors and coworkers.

Laser Engineer

<h3>Job Description</h3>
Job Description
CFD Research is seeking a Structures Engineer to support the Mars Ascent Vehicle Integrated System (MAVIS) Program. The selected candidate will be responsible for developing and designing launch vehicle structures. The candidate will also provide insight to the design team regarding structural changes based on analysis results and provide support to structures team Tabletop Review / Preliminary Design Review products, contractual deliverables, Integrated Product Team meetings, and other meetings and documentation support as needed. The candidate will support development and delivery of contract deliverables related to the design subsystem's structure. This role provides a unique opportunity to contribute to the MAVIS program, one of NASA's most ambitious Mars exploration missions.
 
Required Experience:
<ul>
<li>Bachelor's or Master's degree in Aerospace Engineering, Mechanical Engineering, or a related field.</li>
<li>U.S. Citizenship or Permanent Residency required (ITAR &amp; Export Control compliance).</li>
<li>Experience performing mechanical engineering design and drawing revision and release tasks</li>
<li>Experience using Creo (preferred) or similar CAD software</li>
</ul>
Desired Experience:
<ul>
<li>5+ years in structures design and CAD tools</li>
</ul>
Work Schedule/Location: 
<ul>
<li>3-4 days in the office </li>
<li>9/80 Work Schedule</li>
</ul>
 
About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace &amp; Defense, Biomedical &amp; Life Sciences, Intelligence &amp; Sensing, and Energy &amp; Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for four of the last five years. Learn more at <a href="http://www.cfd-research.com" target="_blank">www.cfd-research.com</a>
 
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers a highly competitive insurance package, including medical, vision, and dental insurance. We offer company paid leave, compensation time, parental leave, long-term and short-term disability, accidental death and dismemberment, and life insurance. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.
CFD Research is an EO employer - Veterans/Disabled and other protected categories
 Job Posted by ApplicantPro

Structures Engineer

<h3>Job Description</h3>
Job Description
POSITION OVERVIEW:
CFD Research is seeking a Stress Engineer to support the Mars Ascent Vehicle Integrated System (MAVIS) Program in Huntsville, Alabama. The selected candidate will be responsible for performing Finite Element Method (FEM) static analysis of launch vehicle structures. The candidate will also provide insight to the design team regarding structural changes based on analysis results and provide support to stress team Tabletop Review / Preliminary Design Review products, contractual deliverables, Integrated Product Team meetings, and other meetings and documentation support as needed. The candidate will support development and delivery of contract deliverables related to the design subsystem's structure. This role provides a unique opportunity to contribute to the MAVIS program, one of NASA's most ambitious Mars exploration missions.
Required Experience:
<ul>
<li>Bachelor's or Master's degree in Aerospace Engineering, Mechanical Engineering, or a related field.</li>
<li>Familiarity with FEM analysis and classical stress and strain methodology (for example: engineering statics, and structural mechanics including hand calculations)</li>
<li>Experience using NASTRAN</li>
</ul>
 
Desired Experience:
<ul>
<li>5+ years in stress analysis and FEM building ability</li>
<li>Strong structural analysis background with demonstrated work experience</li>
<li>Non-linear, and buckling analysis experience</li>
<li>Experience with composite materials and test analysis</li>
</ul>
Schedule:
9/80 Schedule with primary work done in the office.
Clearance: None. U.S. Citizenship or Permanent Residency required (ITAR &amp; Export Control compliance).
 
About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace &amp; Defense, Biomedical &amp; Life Sciences, Intelligence &amp; Sensing, and Energy &amp; Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for four of the last five years. Learn more at <a href="http://www.cfd-research.com" target="_blank">www.cfd-research.com</a>
 
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers a highly competitive insurance package, including medical, vision, and dental insurance. We offer company paid leave, compensation time, parental leave, long-term and short-term disability, accidental death and dismemberment, and life insurance. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.
 
CFD Research is an EO employer - Veterans/Disabled and other protected categories
 Job Posted by ApplicantPro

Stress Engineer

<h3>Job Description</h3>
Job Description
Hemostasis, LLC designs, develops, manufactures and markets advanced hemostat and wound healing technologies for use in the medical device industry. We are currently seeking a Manufacturing Process Engineer to add to our growing team. This role will interface in a collaborative team-based environment with the new product development, manufacturing, research, quality, regulatory, sales, and marketing teams to support and drive the successful implementation of new equipment and continuous improvement of existing products and processes.
The responsibilities of this position include:
<ul>
<li>Define, verify, and validate new processes and modifications to existing products</li>
<li>Perform engineering and quality analysis of processes and prototypes</li>
<li>Develop and execute product/process testing protocols and document results</li>
<li>Collaborate with manufacturing and engineering to ensure manufacturability and execution of fixture builds</li>
<li>Collaborate with automation engineers on the design of assembly equipment</li>
<li>Identify areas of improvement for current processes</li>
<li>Provide product specific technical support as needed</li>
<li>Lead projects or project teams, as needed</li>
<li>Understand and comply with ISO 13485, FDA, and CE requirements</li>
<li>Generate and maintain all aspects of design history records per the Hemostasis Quality Management System for all engineering-based activities relate to new and existing products</li>
</ul>
Position Requirements:
<ul>
<li>Bachelor’s degree in Biomedical or Chemical Engineering</li>
<li>Ability to work in a fast-paced, dynamic work environment with a focus on technical excellence, responsiveness to customer needs and innovative thinking is required</li>
<li>Mechanical aptitude with the ability to understand and optimize manufacturing processes</li>
<li>Demonstrated knowledge and record of developing products within the framework of a QMS</li>
<li>Critical thinking skills with the ability to solve problems and explain solutions</li>
<li>Ability to manage multiple tasks simultaneously, establishing project plans and achieving timelines and communicating results</li>
<li>Demonstrate proactive and strategic thinking and be able to handle change and ambiguity</li>
<li>Strong organizational skills and attention to detail</li>
<li>Excellent written and oral communication skills</li>
</ul>
Hemostasis, LLC, believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement and related benefits.

Manufacturing Engineer

<h3>Job Description</h3>
Job DescriptionSalary: 
Purpose
The Manufacturing Engineer is responsible for bridging the gap between current manufacturing operations and future product development. This role provides technical assistance and engineering support for the operations group while collaborating with Product Development Engineers to ensure design for manufacturability (DFM). The position focuses on improving existing processes, developing new manufacturing concepts, integrating advanced solutions, and ensuring efficient, cost-effective, and quality-driven operations.
Responsibilities
<ul>
<li>Collaborate with New Product Development (NPD) teams to evaluate and enhance product design for manufacturability and scalability</li>
<li>Collaborate with NPD team to ensure effective integration of design control processes, including risk management, verification, validation, and compliance with regulatory standards throughout the product development lifecycle</li>
<li>Define process requirements for new product launches, including equipment selection, process monitoring, and data collection</li>
<li>Create and execute validation and qualification protocols (IQ/OQ/PQ) for new products, equipment, tooling, and processes</li>
<li>Improve existing manufacturing processes and develop new cost-effective concepts</li>
<li>Lead initiatives such as scrap reduction, lean manufacturing projects, and value improvement activities</li>
<li>Evaluate and optimize production layouts and process flows to ensure efficient space utilization and maximize production output</li>
<li>Provide engineering support for various technical production areas</li>
<li>Conduct root cause analysis, implement corrective actions, and resolve material, tooling, and equipment issues</li>
<li>Develop technical solutions in partnership with equipment operations group and support the management of relationships with custom tooling/machine suppliers</li>
<li>Provide technical leadership and mentorship to third-party vendors and cross-functional teams</li>
<li>Assist in training production operators and mentor process technicians on newly developed or improved processes</li>
<li>Generate, update, and implement process documentation, work instructions, and troubleshooting guides</li>
<li>Utilize project management tools to establish timelines, manage action items, and meet milestones</li>
<li>Provide ongoing status reports and periodic progress reviews to management</li>
<li>Identify opportunities for improvement in existing production areas through best practices and potential automation</li>
<li>Execute and document validation activities, including FMEAs, capability studies, control plans, and process verification reports</li>
<li>Maintain a working knowledge of medical device regulations, ISO Standards, cGMP, other relevant regulations/standards, and internal organizational policies and standard operating procedures</li>
<li>File and maintain records in accordance with standard operating procedures Travel domestically and internationally up to 10% to attend offsite meetings, conferences, and support business initiatives</li>
<li>Work overtime during weekdays and on the weekend as needed to support business/operational needs</li>
<li>Perform other duties as assigned</li>
</ul>
Skills
<ul>
<li>Strong knowledge of regulatory standards, including FDA and ISO requirements</li>
<li>New product development and/or new process design skills, including design control knowledge</li>
<li>Mechanical and/or process design, automation, and process validation skills</li>
<li>Root cause analysis and lean manufacturing methodologies knowledge</li>
<li>Six Sigma Green or Black Belt certification preferred</li>
<li>Proficiency in AutoCAD and SolidWorks preferred</li>
<li>Excellent project management, problem solving, and organizational skills</li>
<li>Strong communication skills with the ability to collaborate across teams and departments</li>
<li>Excellent attention to detail and organizational skills</li>
<li>Ability to secure and maintain a favorable background investigation and clearance</li>
</ul>
Qualifications/Requirements
<ul>
<li>Bachelor of Science in an Engineering discipline (Mechanical, Chemical, Industrial, or Biomedical preferred)</li>
<li>Minimum of 5 years of experience in a manufacturing environment; FDA-regulated or medical device industry preferred</li>
<li>Experience in medical device manufacturing and/or cleanroom environments is preferred</li>
<li>Clearance of favorable background investigation required</li>
</ul>

<h3>Job Description</h3>
Job Description
 
Engineer, Manufacturing

Position Summary
The Manufacturing Engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards. This role will also recommend and implement improvements to production processes, methods, and controls and coordinate manufacturing launch for new or revised products. This role will support daily management activities to ensure commitments are achieved and communicated to the customer support teams. 
Principle Responsibilities
<ul>
<li>Develops and implements optimized and cost-effective manufacturing processes and inspection methods (as applicable), in accordance with product specifications and quality standards. </li>
<li>Develops overall engineering project strategies and timelines, including critical path identification and project risks.</li>
<li>Recommends and implements improvements to production processes, assembly methods, and controls by utilizing Lean Manufacturing and Six Sigma tools. </li>
<li>Collaborates with other departments for product tooling, gauging and fixtures design to ensure production methods are robust in support of reducing cost of poor quality and implementing standard work. </li>
<li>Supports creation of PFMEAs, control plans, process flow documents, contact material documents, and other related manufacturing documentation. </li>
<li>Estimates resource requirements, production times, and relative costs to provide data for operational decision-making and to provide data for new program proposals.</li>
<li>Provides design for manufacturing (DFM) feedback for all products, both new and sustaining.</li>
<li>Participates in the engineering change notice process and contract review process for the engineering team to ensure timely release of engineering changes and customer orders.</li>
<li>Utilizes SolidWorks, NX, or other 3D Modeling software to create and/or modify process drawings.</li>
<li>Works closely with cross-functional departments to develop, coordinate, and implement technical training for employees. </li>
<li>Provides engineering support to the production department to troubleshoot and resolve technical problems </li>
<li>Provides support for CNC programming activities.</li>
<li>Further develop and refine Engineering departmental standards and best practices.  </li>
<li>Supports organization and site policies and procedures, goals and objectives, applicable regulations, and good manufacturing practices.</li>
<li>As applicable, read, analyze, and interpret general business periodicals, professional journals, technical procedures, industry standards and governmental regulations.   </li>
<li>Addresses customers’ issues and improves performance, appearance, and impact of product on the end-user.</li>
<li>Provides support to manufacturing, marketing, and customer service, interfaces with customers and suppliers.</li>
<li>Applies critical thinking skills to solve practical problems that incorporate a variety of inputs in multi-variable scenarios. </li>
<li>Performs other duties or special projects as required or as assigned by supervisor.</li>
</ul>
Qualification Requirements
Credentials/Experience:
<ul>
<li>Bachelor's degree in engineering (biomedical engineering, mechanical engineering, manufacturing engineering, industrial engineering, material sciences) or an engineering technical field is required. Training in a manufacturing environment with equivalent combination of education and experience will be considered.</li>
<li>2+ years of experience in similar manufacturing / engineering position or equivalent.</li>
<li>2+ years’ experience in CNC machining and/or other manufacturing processes.</li>
<li>Demonstrated engineering experience in a high precision machine shop and/or assembly environment with moderate to high complexity products.</li>
<li>Experience and demonstrated proficiency in the use of Mastercam, Solidworks, CREO/ProE or other CAD/CAM software. </li>
</ul>
Experience/Educational/Training Preferred:
<ul>
<li>Experience in aerospace and defense manufacturing is highly preferred.</li>
<li>Secondary processes experience (welding, brazing, polishing, passivation, heat treat, assembly) desired</li>
</ul>
Knowledge, Skills, and Abilities: 
<ul>
<li>Strong interpersonal skills: Ability to relate to and work with diverse groups of people. Coordinates project activities and resolves individual conflicts and issues. Handles sensitive and confidential situations and materials.</li>
<li>Strong working knowledge of manufacturing methods, processes (i.e. machining methods, forging process, automation, heat treat methods, finishing, and polishing, material handling, basic machine design and metal fabrication. </li>
<li>Understanding of GD&amp;T and fundamental engineering principles</li>
<li>Good knowledge of lean manufacturing principles and ability to implement of Lean and Six Sigma techniques in business and manufacturing systems</li>
<li>Ability to develop collaborative relationships with customers, vendors, and team members within the organization. </li>
<li>Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals.</li>
<li>Demonstrated organizational skills with the ability to handle and prioritize multiple projects/tasks simultaneously in a timely manner in a fast-paced environment.</li>
<li>Possess engineering, analytical and problem-solving skills</li>
<li>Proficient in modern computer aided design (CAD) software, Solidworks or NX preferred</li>
<li>Proficient in modern computer aided manufacturing (CAM) software such as MasterCam</li>
<li>Knowledge of applicable regulatory requirements and concepts including ISO 13485, ISO 14971, MDR 2017/745, CAPA, NCR, supplier control, manufacturing control, design control.</li>
<li>Knowledge of Design of Experiments, Control Plans, PFMEA, DMAIC Model. </li>
<li>Sound written and oral communication skills. Ability to provide written and/or oral communication to management and technical staff audiences.</li>
<li>Excellence in Microsoft Word, Excel, and PowerPoint</li>
<li>Ability to prioritize and work independently with a sense of urgency</li>
</ul>
Other Requirements 
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision, and ability to adjust focus. 
Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.
 
Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

Engineer, Manufacturing

<h3>Job Description</h3>
Job Description
Join VitalPath in Maplewood as a Manufacturing Engineer I!
 About VitalPath VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members. Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence. As a fast-growing organization, we bring harmony and standardization across VitalPath with a strong vision in mind - We are one VitalPath. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that VitalPath is an employer of choice. If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth! About the Position The Manufacturing Engineer I will be responsible for the support and troubleshooting of manufacturing floor, processes and assembly with direct participation in managing CIs, quality issues investigations NMRs in order to ensure full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the VitalPath Quality Management System (QMS), including development and maintenance of documentation. Work Location/Schedule •&nbsp;&nbsp; &nbsp;This position requires the employee to be onsite at our Maplewood, MN location. This position may require minimal travel to other VitalPath locations. •&nbsp;&nbsp; &nbsp;VitalPath does not offer relocation assistance for this position. Responsibilities •&nbsp;&nbsp; &nbsp;Support the troubleshooting of equipment and manufacturing processes. •&nbsp;&nbsp; &nbsp;Develop bills of materials and assembly methods, update work instructions and provide any needed training to technicians and assemblers related to processes and equipment. •&nbsp;&nbsp; &nbsp;Work in a cross-functional environment partnering with RD and Quality departments in order to deliver product that meets customer requirements, on time delivery and quoted price. •&nbsp;&nbsp; &nbsp;Create tooling and fixtures to improve the manufacturing processes and ease the operators job in the assembly area. •&nbsp;&nbsp; &nbsp;Support and execute CI projects in order to reduce the cost and improve yields in the production area. •&nbsp;&nbsp; &nbsp;Working knowledge of manufacturing processes related to catheter manufacturing. •&nbsp;&nbsp; &nbsp;Provide technical support for NMRs and customer complains investigations, performing root cause analysis, data retrieval and tests needed and required by customers or other project related issues. •&nbsp;&nbsp; &nbsp;Participates in the execution of protocols for Qualifications, Validations, Verification and Validation testing, and Process FMEAs.&nbsp; •&nbsp;&nbsp; &nbsp;Actively participate in all Lean manufacturing events and initiatives taking place on manufacturing floor. •&nbsp;&nbsp; &nbsp;Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.&nbsp; •&nbsp;&nbsp; &nbsp;Other duties as assigned. Required Qualifications •&nbsp;&nbsp; &nbsp;High School Diploma or GED •&nbsp;&nbsp; &nbsp;1 to 3 years in a medical device manufacturing environment, with exposure to product design and Fixture design. •&nbsp;&nbsp; &nbsp;Demonstrated excellent written and oral communication skills.&nbsp; •&nbsp;&nbsp; &nbsp;Understanding of Lean principles and basic Lean Tools. •&nbsp;&nbsp; &nbsp;Experience with design controls, FDA regulation, GMP practices, and QSR requirements. Preferred Qualifications •&nbsp;&nbsp; &nbsp;Bachelor's degree in Plastics, Chemical, Biomedical or Mechanical Engineering •&nbsp;&nbsp; &nbsp;A working Knowledge of catheter assembly manufacturing processes.&nbsp; Compensation Package •&nbsp;&nbsp; &nbsp;The salary range for this position is $65,934 - $83,154. The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity.&nbsp; •&nbsp;&nbsp; &nbsp;This position is eligible to earn an annual performance bonus based on meeting VitalPath’s bonus performance plan. Benefits •&nbsp;&nbsp; &nbsp;Comprehensive, Low Cost Health and Dental Insurance Plans Available •&nbsp;&nbsp; &nbsp;Vision Insurance •&nbsp;&nbsp; &nbsp;Health Savings Account with company contribution •&nbsp;&nbsp; &nbsp;Short and Long Term Disability •&nbsp;&nbsp; &nbsp;Supplemental insurances (short term disability, AD&amp;D, life insurance, and more) •&nbsp;&nbsp; &nbsp;Parental Leave •&nbsp;&nbsp; &nbsp;Paid Time Off •&nbsp;&nbsp; &nbsp;Minnesota Earned Sick &amp; Safe Time •&nbsp;&nbsp; &nbsp;Paid Holidays •&nbsp;&nbsp; &nbsp;401K with company match •&nbsp;&nbsp; &nbsp;Opportunities for career growth and advancement
VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.
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